Duns Number:092673953
Device Description: Universal, Neonatal, NeoPod Transport Circuit with Exhalation Valve, Lavabed
Catalog Number
-
Brand Name
NeoPod
Version/Model Number
9403
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
Yes
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K870173,K870173
Product Code
BTT
Product Code Name
Humidifier, Respiratory Gas, (Direct Patient Interface)
Public Device Record Key
1fd44569-628a-4dab-9582-760c6baad120
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
April 11, 2017
Package DI Number
10709078002288
Quantity per Package
20
Contains DI Package
00709078002281
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 746 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 320 |